- AbbVie (South San Francisco, CA)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Biologics CMC Development team at AbbVie in the Bay Area has a long and ... South San Francisco, the team leverages its comprehensive end-to-end CMC capabilities to work collaboratively through all phases of...to human clinical studies and eventual licensure. This Principal Scientist I role is within a team of highly… more
- Frontier Medicines (South San Francisco, CA)
- Join Frontier Medicines on an exciting journey as our newest Principal Scientist /Associate Director, CMC Development located at our South San Francisco office. ... of our team, reporting directly to the Head of CMC , you'll play an integral role in advancing our...writing skills + A thorough understanding of ICH guidelines, GLP/ GMP manufacturing, and related regulatory requirements is required +… more
- Amgen (Cambridge, MA)
- …It's time for a career you can be proud of. Process Development Senior Principal Scientist - CMC Team Lead **Live** **What you will do** Let's do this. ... within the analytical sciences space. + Author chemistry, manufacturing and controls ( CMC ) sections in regulatory files, lead the preparation of responses to… more
- AbbVie (South San Francisco, CA)
- …Facebook, Instagram, YouTube and LinkedIn. Job Description The Development Sciences Biologics CMC Drug Substance Cell Line Development Group in South San Francisco, ... CA is seeking a Scientist to join a talented and collaborative team developing...talented and collaborative team developing CHO cell lines for GMP applications. In this laboratory position, the candidate will… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …in a manner that facilitates Health Authority reviews. - Supports company`s GMP Change Management Program. Evaluates CMC changes for portfolio biologics ... Associate Director, RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio small… more
- Takeda Pharmaceuticals (Boston, MA)
- …identification and phase appropriate route development to deliver GLP Tox and Ph 1 GMP Drug Substance (DS). The PR team is accountable for process knowledge transfer ... (PC) team in SMPD. Join Takeda as a Sr Scientist , Process Research (PR) where you will play a...support of the development and implementation of an overall CMC strategy. + Ability to lead all or part… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Gilead and help create possible, together. **Job Description** **Senior Research Scientist II, Purification Development - Pre-Pivotal Biologics - Foster City, CA** ... and help create possible, together. **Job Description** The Senior Research Scientist II, Purification Process Development (Pre-Pivotal) will be responsible for… more
- Teva Pharmaceuticals (West Chester, PA)
- …of formulation, drug product manufacturing process, and process tech transfer to GMP manufacturing sites. As a Scientist , the successful candidate will ... Scientist , Drug Product Development Date: May 24, 2024...and over-the-counter therapies. Located in West Chester, PA, Biologics CMC is a division of Teva Pharmaceuticals responsible for… more
- Amgen (Cambridge, MA)
- …patients worldwide. It's time for a career you can be proud of. **Principal Scientist ** **Live** **What you will do** Let's do this! Let's change the world! In ... phase synthetic small molecule, synthetic peptide, and/or siRNA programs. The Scientist will integrate and optimally utilize platform and in-depth product attribute… more
- Amgen (Thousand Oaks, CA)
- …patients worldwide. It's time for a career you can be proud of. **Principal Scientist ** **Live** **What you will do** Let's do this! Let's change the world! In ... + Author technical reports and analytical Chemistry, Manufacturing and Controls ( CMC ) sections in regulatory documents. Answer analytical and product quality… more
- AbbVie (Irvine, CA)
- …at AbbVie. We have an exciting opportunity for a Senior Separations Scientist position based in Irvine, CA. + Lead the development, qualification, validation ... new technologies to contribute to future business developments and improvements. + Author CMC analytical sections of BLA and other CMC regulatory packages,… more
- AbbVie (South San Francisco, CA)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Biologics CMC Development team at AbbVie in the Bay Area has a long and ... South San Francisco, the team leverages its comprehensive end-to-end CMC capabilities to work collaboratively through all phases of...modalities, to human clinical studies and eventual licensure. This Scientist I role is within a team of highly… more
- Lundbeck (Bothell, WA)
- Senior Scientist , Potency Assays for Antibodies Requisition ID: 5273 Location: Bothell, Washington, US Do you want to join a team where the mission is meaningful, ... Process Development Center of Excellence for Biologics within the global Lundbeck CMC organization. Since integrating into Lundbeck in October 2019, Lu-SBP has… more
- Catalent Pharma Solutions (St. Petersburg, FL)
- ** Scientist II, Analytical Research & Development** **Position Summary** Catalent is a global, high-growth, public company and a leading partner for the ... analytical services to solve difficult development and manufacturing challenges. The ** Scientist II, Analytical Research & Development** will independently test Raw… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …uses state-of-the art technologies to develop, enable and execute analytical and CMC strategies that ensure safety, quality and efficacy of life-saving medicines ... GxP laboratory seeks a hard-working, results-focused Research & Development (R&D) scientist with experience in protein analysis to bring a world-class R&D… more
- Boehringer Ingelheim (Gainesville, GA)
- …and technical application of Good Laboratory and Manufacturing Practice (GLP/ GMP ) regulations, regulatory guidance for industry and other applicable regulations ... "how to" guidance and application for required data & information for CMC , product manufacture & delivery (eg manufacturing processes, quality, supply chain &… more
- AbbVie (Irvine, CA)
- …Facebook, Instagram, YouTube and LinkedIn. Job Description The Principal Research Scientist I is responsible for ensuring uninterrupted operations of testing ... will be involved in day-to-day operations of the department. The Principal Research Scientist I will lead groups of analysts engaged in laboratory support operations… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and help create possible, together. **Job Description** The **Senior Research Scientist I, Biologics Pre-Pivotal Formulation and Process Development** role is part ... of the collaborative and interdisciplinary CMC development team aiming to use state-of-the art technologies and innovative methodologies to advance medicines into… more
- Gilead Sciences, Inc. (Foster City, CA)
- …pre-formulation, formulation and process development, Quality by Design (QbD), oversight of GMP drug product manufacturing and global regulatory CMC (INDs, ... Join Gilead and help create possible, together. **Job Description** **Sr. Research Scientist II, Formulation & Process Development** Gilead Sciences, Inc. is a… more
- Takeda Pharmaceuticals (Boston, MA)
- …identification and phase appropriate route development to deliver GLP Tox and Ph 1 GMP Drug Substance (DS). The PR team is accountable for process knowledge transfer ... 1 to the downstream Process Chemistry (PC) team in SMPD. Join Takeda as a Scientist , Process Research where you will play a crucial role in advancing our mission by… more